Research Article

Pharmacist Mediated Assessment and Reporting of

Adverse Drug Reactions in a Tertiary Care Hospital
Inamdar Syed Zia1,*, Pradeepthi K1, Ashwini N2, Soumyashree L2, Kulkarni R.V1
1
Department of Pharmacy Practice, BLDEA’s SSM College of Pharmacy and Research Centre, Vijaypur 586 103, Karnataka, INDIA.
2
Intern Pharm D, BLDEA’s SSM College of Pharmacy and Research Centre, Vijaypur 586 103, Karnataka, INDIA.

ABSTRACT
Background: ADRs are one of the foremost reasons of illness and death, adding to overall preventive medicine
cost. Reporting of such adverse drug reactions are critical parameter of medical treatment. The present study
assess the clinical pharmacist role in drug monitoring to detect and intercept adverse drug reaction in a health
care setting, Method: A prospective observational was conducted at tertiary care hospital in Vijaypur city. A total
of 50 suspected adverse effects were recognized and documented during the study period of six months. The
suspected adverse effects were assessed for its causality and severity by using Naranjo’s and Hartwig’s scale.
Results: Overall 50 ADRs were identified and documented during the study period. Most of the reported ADRs
in this study were Type A 34(68%). Drug dose and frequency 18(33.96%), Age 15(28.3%) and polypharmacy
10 (18.86%) were the furthermost protruding predisposing factors of ADRs were observed. Antibiotics were the
common class of drugs involved in producing ADRs 14(28%).Causality assessment by Naranjo’s scale presented
that majority of the reported ADRs were found to be probable 26(52%), possible 19(38%) and definite 3 (6%).
Severity assessment by Hartwig’s scale showed that 26(52%) ADRs were moderate, 17 (34%) ADRs were
mild and 7(14%) ADRs were of severe. Withdrawal of the drug 27(54%) as a management intervention was
the core line of the adverse drug effect management. Conclusion: Clinical Pharmacist preparedness towards
pharmacovigilance approach and proximity for drug monitoring resulted in greater interception and reporting of
adverse effect ensuring patient drug related safety.
Key words: Adverse drug reaction, Pharmacovigilance, Severity, Causality, Clinical pharmacist.

INTRODUCTION
The concept of ADR (Adverse Drug
Reaction) monitoring and reporting system
in India is out there for a considerable
time and slowly but steadily gaining its
due importance in drug safety measures.
Deficiency in real ADR reporting and
monitoring in Indian population for drug
safety is still a huge challenge among health
care professional. Therefore, to increase the
reporting rate, it is important to improve
the knowledge, attitude and practice of
healthcare professionals regarding ADR
their individual set of guidelines on
Pharmacovigilance for detection, collection, DOI: 10.5530/ijopp.11.3.28
assessment of adverse events in their
Address for
corresponding regions. The final aim of correspondence:
Pharmacovigilance is to safeguard safe Dr. Syed Zia Inamdar,
Associate Prof and Clinical
and rational use of medications.2 “No drug Pharmacist, Department of
absolutely is free from side effects” which is Pharmacy Practice,
BLDEA’s SSM College of
universally accepted statement.3 According Pharmacy and Research Centre,
to World Health Organization (WHO), the Vijaypur 586 103, Karnataka,
INDIA.
term ADR can be defined as “Any response Phone no: 9986666016
to a drug which is noxious and unintended, Email Id: syedzia.inamdar@
and which occurs at doses normally used in gmail.com

reporting and pharmacovigilance.1 WHO man for prophylaxis, diagnosis, or therapy

defines the Pharmacovigilance (PV) as “the
pharmacological science relating to the
detection, evaluation, understanding and
prevention of adverse effects, particularly
long term and short-term side effects of
medicine.” Every country has established
of disease or for the modification of
physiological function”. Pharmacovigilance
plays a significant part in the investigation of
adverse drug reactions, a significant reason
of illness and death. Present epidemiological
studies assessed that ADRs are fourth to www.ijopp.org

126 Indian Journal of Pharmacy Practice, Vol 11, Issue 3, Jul-Sep, 2018
 Inamdar, et al.: Pharmacist Mediated Assessment and Reporting of ADR’s

sixth foremost root of death.4-5 ADRs causes important
economic burden on national health budget. It raises
costs of patient care and may mimic disease leading
to unnecessary investigations and delay in treatment.5
So there is a need to study ADRs seriously, to create
consciousness about it among patients, to encourage
healthcare professionals in reporting ADRs to reduce the
risk.6 The pharmacist and the prescriber have a duty to
safeguard patients with the risk of untoward drug effects.
The pharmacist are appropriately placed in the whole
medication use process, are accessible and important
link between the patient and the physician. A thorough
knowledge of medicine and drug monitoring skills of
pharmacist plays major role in the promotion of drug
safety and optimizing patient outcomes.1 The present
study aims to recognize and illustrate the pattern of
ADRs due to frequently used drugs with their possible
contributing factors from the prospective role of a clinical
pharmacist in drug monitoring and ADRs management.
MATERIALS AND METHODS
A prospective observational study was carried out for
a period of six months in the selected departments
of a tertiary care hospital in Vijaypur city. The study
was approved by Institutional Ethical Committee. The
inpatients of the selected department who are receiving
treatment in the hospital at the time of the study were
routinely monitored by the clinical pharmacist on day
to day basis. Any episode of suspected ADRs detection
or its occurrence was reported and documented by the
pharmacist on a standard data collection form prepared
in accordance to CDSCO ADR reporting template.
Supplementary information was also extracted by
interacting with the patient’s and reviewing patient case
files (including patient’s specific information, laboratory
investigations and drug therapy). The suspected ADR was
further followed for its management and assessed for its
causality and severity using Naranjo’s and Hartwig’s scale.
10(18.86%), therapeutic index of drug 4(7.54%),
allergy 4(7.54%), smoking 1(1.88%) and Alcohol
1 (1.88%) [Figure 2]. The most common therapeutic
class involved in ADRs was Antibiotics 14(28%) while
others were steroids 5(10%), antihypertensive drugs
4(8%), NSAIDS 3(6%), anticoagulants 3(6%), antiviral
3(6%), antiulcer drugs 2(4%), anti-malarial2(4%),
antitubercular 2(4%), diuretics 2(4%), neurotransmitters
2(4%), bronchodilators 2(4%), antiepileptic 1(2%),
antifungal 1(2%), anti-Hyperlipidemia 1(2%), mucolytics
1(2%), antihistamines 1(2%) and vitamin supplement
1(2%) [Figure 3]. Causality assessment by Naranjo’s
scale showed that out of 50 ADRs, 26(52%) were
probable, 19(38%) were possible, 3(6%) were definite
and 2(4%) were doubtful. [Figure 4] By using Hartwig’s
scale, Severities of the reactions were assessed. Among
the reported ADRs, 26(52%) were moderate reactions
followed by 17(34%) were mild reactions and 7(14%)
were severe [Figure 5]. Management of ADRs in the
study showed that out of 50 ADRs, 27(54%) ADRs
were managed by withdrawing suspected drug, 13(26%)
ADRs were managed by adding a supplement, 12(24%)
ADRs were managed by replacing a drug, 2(4%) ADRs
were managed by altering the dose while no change was
made in 2(4%) ADRs [Figure 6].
Figure 1:  Types of Adverse Drug Reactions.

RESULTS
Overall 50 ADRs were identified and documented
during the six months study period. Among them
4(8%) inpatients were admitted due to ADR reason and
during their hospital stay 46(92%) patients developed
ADR. Among the reported ADRs in terms of patient
demographics, 30(60%) were male and 20 (40%) were
female. The majority of the ADRs were of Type A
34(68%) followed by Type B 14(28%) and Type F 2
(4%) [Figure 1]. Of the reported ADRs, the prominent
predisposing factor was drug dose and frequency
18(33.96%) followed by age 15(28.3%), polypharmacy Figure 2:  Predisposing factors of Adverse Drug Reactions.

Indian Journal of Pharmacy Practice, Vol 11, Issue 3, Jul-Sep, 2018 127
 Inamdar, et al.: Pharmacist Mediated Assessment and Reporting of ADR’s
Figure 3:  Therapeutic classes of drug wise distribution of Adverse Drug
Reactions.
Figure 4: Causality assessment of Adverse Drug Reactions (Using
Naranjo’s scale).
DISCUSSION
A total of 50 suspected ADRs were identified and
documented during this six months study period. It was
found out that there were more number of ADRs in males
30(60%) compared to females 20(40%) in our hospital.
This may be due to majority of in-patients were male
with more antibiotic use during the study period. Some
of the factors like smoking and alcohol intake may also be
an important risk factor to develop ADRs more in male
gender. This result is reliable with the results of the study
carried out by Shamna M et al.7 The analysis of the types
of reported ADRs revealed that more number of ADRs
were of type A comprising about 34(68%) followed by
type B comprising about 14(28%) and followed by type
F of 2(4%). Drug dosing and frequency plays a vital
role in the development of ADRs as type A reactions
are dose related and therefore, can be preventable from
their known pharmacology and type B reactions mostly
include hypersensitivity reactions. Even though, majority
of the reactions we found are of moderate type, due to
this reason the health care cost were increased which
was due to an increased length of stay and necessity of
some medical interventions as a result of prevalence of
adverse drug reactions. This result was reliable with the
128
Figure 5:  Level of severity of reported Adverse Drug Reactions (using
Hartwig’s Scale).
Figure 6:  Management of Adverse Drug Reactions.
study carried out by Shamna M et al.7 Drug dose and
frequency 18(33.96%), age 15(28.3%), polypharmacy
10(18.86%) were the utmost protruding predisposing
factors of ADRs. A total of 50 suspected ADRs were
identified during study period and predisposing factors
tend to be 53, this may conclude that an ADR occurring
in some individual patients may be due to exposure of
more than one predisposing factor. There might be some
effect on the development of ADRs thus, dosing needs
should be considered as a factor. Associated patient’s
disease may also effect susceptibility to ADR’s as majority
of the patients who developed ADRs were having
co-morbidities like diabetes, hypertension, COPD,
bronchial asthma, cirrhosis, tuberculosis etc., necessitating
them to receive multiple drugs, which contributes to the
increased risk of ADRs. In order to prevent potential
ADRs which affect patient health status, compliance
and therapeutic outcomes polypharmacy should be
considered. This result was inconsistent to a study
conducted by Dilip C et al.4 This study revealed that
antibiotics were the most commonly implicated drug class
as antibiotics drugs are highly consumed in our hospital to
treat various diseases, which is similar to a study conducted
by Shamna M et al.7 Most of the antibiotics are known to
Indian Journal of Pharmacy Practice, Vol 11, Issue 3, Jul-Sep, 2018
 Inamdar, et al.: Pharmacist Mediated Assessment and Reporting of ADR’s
cause GI related side effects and GIT was found to be
the most affected organ in our study for the precipitation
of ADRs which ultimately lead to GI side effects (loose
motions, vomiting and abdominal pain). Causality was
assessed as per Naranjo’s Scale through patient interview
and interaction with doctors and healthcare professionals.
According to Naranjo’s scale, probable were 26(52%),
possible 19(38%), definite 3(6%) and doubtful 2(4%)
which is similar to a study conducted by Khan A
et al.8 The assessment and establishment of causality
relationship between suspected drugs and reactions can
help in signal generation and drug regulation. This serves
as useful reference to alert clinicians to the likelihood of a
particular drug causing a suspected reaction. To assess the
level of severity of reported ADRs Hartwig’s scale was
used, which revealed that moderate cases were 26(52%),
mild cases were 17(34%) and 7(14%) of severe cases,
which is similar to a study conducted by Padmavathi S
et al.9 Most of the patients on multiple drug therapy
developed more number of moderate level severity
reaction than others. Drug stopped 27(54%) was the
foremost line of management of ADRs while supplement
added were 13(26%), drug replaced 12(24%), dose altered
2(4%) and no change was made with the suspected drug
in 2(4%). This result was reliable with the study carried
out by Patidar D et al.10
CONCLUSION
The lively participation of clinical pharmacists can plays a
significant role in the identification and documentation of
ADRs by virtue of their role in patient drug monitoring.
The health care prescriber’s has diminutive ADR
reporting culture due to patient overload and to a certain
extent a deficiency of interest to report ADRs. ADRs
are unique drug related problems in the hospital setting
and preventing them is a task for safeguarding drug
safety. Major number of ADRs was caused by antibiotic
drugs due to advanced prescription use of antibiotics
for prophylaxis and treatment of various diseases. The
healthcare system should encourage and adopt clinical
pharmacy services rendered by clinical pharmacist to
promote drug safety and rational use of drugs among
patient population to optimize treatment outcomes.
ACKNOWLEDGEMENT
The authors are thankful to the management of BLDE
association for supporting the work.
Indian Journal of Pharmacy Practice, Vol 11, Issue 3, Jul-Sep, 2018
CONFLICT OF INTEREST
The authors declare no conflict of interest.
ABBREVIATIONS
ADR: Adverse Drug Reactions, WHO: World Health
Organization, PV: Pharmacovigilance, CDSCO:
Central Drug Standard Control Organization, NSAID:
Non Steroidal Anti- Inflammatory Drugs, GI: Gastro
Intestinal, COPD: Chronic Obstructive Pulmonary
Disease, GIT: Gastro Intestinal Tract.
SUMMARY
Drug safety measures are still a huge challenge and
contribute significantly to the health and economic burden
in a patient care process. The deficient reporting culture
of ADRs by health professionals further potentiates the
problem. The pharmacist, through its apparent role in
drug monitoring can assist and promote drug safety and
safeguard patients with the risk of untoward drug effects.
REFERENCES
1. Lihite RJ, Lahkar M. An update on the Pharmacovigilance Programme of
India. Front Pharmacol. 2015;6(194). doi: 10.3389/fphar.2015.00194
2. Rabbur RSM, Emmerton L. An introduction to adverse drug reaction reporting
system in different countries. Int J Pharm Prac. 2005;13(1):91-100.
3. Sulthan MS, Bawazir SA. Adverse drug reporting by Hospital Pharmacist in
Saudi Arabia. Saudi Pharmaceutical J. 2009;17(1):95-105.
4. Dilip C, Lisa MM, Saraswathi R, Divya R. Adverse drug reaction monitoring in
a tertiary level referral hospital, Kerala. Ind J Pharm Prac. 2012;5(2):28-32.
5. Srinivasan R, Ramya G. Adverse Drug Reaction-Causality Assessment. Int J
Res Ph and Chem. 2011;1(3):606-12.
6. American Society of Health-System Pharmacists. ASHP guidelines on
Adverse drug reaction monitoring and Reporting. An J Health-Syst Pharm.
1995;52(4):417-9
7. Shamna M et al. A prospective study on adverse drug reactions of antibiotics
in a tertiary care hospital. Saudi Pharmaceutical Journal. 2014;22(4):303-8.
doi: 10.1016/j.jsps.2013.06.004
8. Khan A, Mir SA, Nematullah K, Ihtisham S, Aamer K, Aamir S. Causality
assessment of adverse drug reaction in Pulmonology Department of a Tertiary
Care Hospital. Journal of Basic and Clinical Pharmacy. 2015;6(3):84-8.
doi: 10.4103/0976-0105.160744
9. Padmavathi S, Manimekalai K, Ambujam S. Causality, Severity and
Preventability assessment of adverse cutaneous drug reaction: A
prospective observational study in a Tertiary Care Hospital. J Clin Diagn Res.
2013;7(12):2765-7. doi: 10.7860/JCDR/2013/7430.3753
10. Patidar D, Rajput MS, Nirmal NP, Savitri W. Implementation and evaluation
of adverse drug reaction monitoring system in a Tertiary Care Teaching
Hospital in Mumbai, India. Interdiscip Toxicol. 2013;6(1):41-6. doi: 10.2478/
intox-2013-0008
11. Gupta SK, Nayak RP, Shivaranjani R, Vidyarthi SK. A questionnaire study on
the Knowledge, Attitude, and Practices of Pharmacovigilance among health
care professionals in a teaching hospital in South India. Perspect Clin Res.
2015;6:45-52.
129